Nov. 5, 2010 – A drug used to treat depression, anxiety, fibromyalgia, and diabetic neuropathy has been approved by the FDA for a new use -- to treat chronic musculoskeletal pain, including pain caused by osteoarthritis and chronic low back pain.
The drug is sold under the brand name Cymbalta (duloxetine hydrochloride) and is manufactured by Eli Lilly and Co., a major pharmaceutical company based in Indianapolis. Chronic low back pain is one of the most common forms of musculoskeletal pain, and finding an effective treatment can sometimes be challenging.
The approved dose for chronic musculoskeletal pain is a 60-milligram capsule taken once a day, swallowed whole; it does not have to be timed with meals.
"Up to three-quarters of the population experience chronic pain at some time in their lives," Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, said in a prepared statement."This approval means that many of those people now have another treatment option."
Clinical trials showed that taking Cymbalta significantly reduced chronic pain, compared with a placebo. More than 29,000 patients used Cymbalta in clinical trials, including people with osteoarthritis and chronic low back pain.
The most common side effects among Cymbalta users were nausea, dry mouth, insomnia, drowsiness, constipation, fatigue, and dizziness. There were serious side effects as well, including liver damage, hives, rashes, swelling in the face, pneumonia, depressed mood, and suicidal thoughts and behavior. These more serious side effects have occurred in less than 1% of patients taking Cymbalta.
Since its approval in 2004, an estimated 30 million people have used Cymbalta.